Health Condition 1: null- Non-small cell lung cancer (NSCLC) subjects with unresectable stage III disease
Conditions
Interventions
Intervention1: Investigational arm: Pre-treatment: one intravenous infusion of cyclophosphamide (infusion of 300 mg/m2, determined by calculation of the subject'
s body surface area. A maximum dose of 600mg will be given). Primary treatment: weekly subcutaneous vaccinations with Stimuvax (subcutaneous injection of 1,000 µ
g) for 8 consecutive weeks. Maintenance treatment: vaccinations with Stimuvax (subcutaneous injection of 1,000 µ
g) at 6-week intervals. Subjects will be discontinued upon documented disease progression.:
Intervention2: Investigational arm: Pre-treatment: one intravenous infusion of cyclophosphamide (infusion o
g) at 6-week intervals. Subjects will be discontinued upon documented disease progression:
Control Intervention1: Placebo arm: A single infusion (IV) of 0,9% Saline solution instead of Cyclophospham
6 and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at week 13, until disease progression is documented.:
Control Intervention2: Placebo arm: A single infusion (IV)
Sponsors
Merck KGaA, Darmstadt, Germany
Frankfurter Strasse 250 D-64293 Darmstadt
Germany
Merck'
s USA affiliate, EMD Pharmaceuticals Inc., Durham, NC, USA
Durham, NC
United States of America
Eligibility
Inclusion criteria
Inclusion criteria: 1.Histologically or cytologically documented unresectable stage III NSCLC. 2.Documented stable disease or objective response, according to RECIST, after primary chemoradiotherapy (either sequential or concomitant) for unresectable stage III disease, within 4 weeks(28 days) prior to randomization. 3.Receipt of concomitant or sequential chemoradiotherapy, consisting of a minimum of two cycles of platinum-based chemotherapy and a minimum radiation dose of ≥ 50 Gy. Subjects must have completed the primary thoracic chemo-radiotherapy at least four weeks (28 days) and no later than 12 weeks (84 days) prior to randomization. Subjects who received prophylactic brain irradiation as part of primary chemo-radiotherapy are eligible. 4. Geographically accessible for ongoing follow-up, and committed to comply with the designated visits. 5.An ECOG performance status of 0-1.
Exclusion criteria
Exclusion criteria: ? Pre-Therapies: o Undergone lung cancer specific therapy (including surgery) other than primary chemo-radiotherapy. o Receipt of immunotherapy (e.g. interferons, tumor necrosis factor [TNF], interleukins, or biological response modifiers [granulocyte macrophage colony stimulating factor {GM-CSF}, granulocyte colony stimulating factor {G-CSF}, macrophage-colony stimulating factor {M-CSF}], monoclonal antibodies) within 4 weeks (28 days) prior to randomization. o Receipt of investigational systemic drugs (including off-label use of approved products) within 4 weeks (28 days) prior to randomization. ? Disease Status: o Metastatic disease o Malignant pleural effusion at initial diagnosis and at study entry. o Past or current history of neoplasm other than lung carcinoma, except for curatively treated nonmelanoma skin cancer, in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years. o Autoimmune disease that in the opinion of the investigator could compromise the safety of the subject in this study. o A recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have hereditary or congenital immunodeficiencies. o Any preexisting medical condition requiring chronic steroid or immunosuppressive therapy (steroids for the treatment of radiation pneumonitis are allowed). o Known Hepatitis B and/or C. ? Physiological Functions: o Clinically significant hepatic dysfunction. o Clinically significant renal dysfunction. o Clinically significant cardiac disease. o Splenectomy. o Infectious process that in the opinion of the investigator could compromise the subject's ability to mount an immune response. ? Standard Safety: o Pregnant or breast-feeding women, women of childbearing potential, unless using effective contraception as determined by the investigator. o Known drug abuse/alcohol abuse. o Legal incapacity or limited legal capacity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢To compare survival duration of all randomized subjects by treatment armTimepoint: [ Time Frame: various timepoints ] [ Designated as safety issue: No ];â?¢To compare survival duration of all randomized subjects by treatment armTimepoint: [ Time Frame: various timepoints ] [ Designated as safety issue: No ] | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ to compare all randomized subjects by treatment arm for: Time To Symptom Progression (TTSP) as measured by the Lung Cancer Symptom Scale (LCSS) [ Time Frame: various timepoints ] [ Designated as safety issue: No ]Timepoint: â?¢ Time To Progression (TTP) as determined by the investigator [ Time Frame: various timepoints ] [ Designated as safety issue: No ] â?¢ one-, two- and three-year survival [ Time Frame: various timepoints ] [ Designated as safety issue: No ] â?¢ Safety [ Time Frame: various timepoints ] [ Designated as safety issue: Yes ] ;Secondary Outcome Measures:Timepoint: â?¢ to compare all randomized subjects by treatment arm for: Time To Symptom Progression (TTSP) as measured by the Lung Cancer Symptom Scale (LCSS) [ Time Frame: various timepoints ] [ Designated as safety issue: No ] â?¢ Time To Progression (TTP) as determined by the investigator [ Time Frame: various timepoints ] [ Designated as safety issue: No ] â?¢ one-, two- and three-year survival [ Time Frame: various timepoints ] [ Designated as safety issue: No ] â?¢ Safety [ Time Frame: various timepoints ] [ Designated as safety issue: Yes ] | — |
Countries
Democratic People's Republic of Korea, India
Contacts
Public ContactDr Khokan Debnath
Outcome results
None listed